This invention relates to a device for immobilizing an eyelid of an injured eye by means of an eyelid splint. In particular, it relates to a shield attached to a head-encircling strap, with the shield having a thick, resilient pad attached to its interior surface by means of a "low-peel" adhesive.
Eyelid splints having backing members attached to foam pads are described in my previous U.S. Pat. No. 4,677,974 and U.S. Pat. No. 4,727,869, each entitled "Method And Apparatus For Immobilizing An Eyelid". The eyelid splints described in these patents have a variety of uses in the medical field, generally being used in cases in which the eyelid must be maintained in a fixed, closed position to permit healing. Eyelid immobilization is indicated for corneal abrasions, corneal burns, keratitis, and following corneal or cataract surgery. Eyelid immobilization is also helpful to prevent injuries to the cornea from drying when a patient is unable to close the eyelid due to neurologic deficiencies caused by e.g., Bell's palsy, stroke, head injury, or coma. The products described in my previous patents include eyelid splints which are mounted on the head of the patient by a pair of head-encircling straps. The straps are elastic, and the lengths are adjustable, in order to adjust the pressure of the splint against the eyelid. The pads are adhered to an inner surface of a backing shield and consist of a thick, resilient foam which, upon compression, assumes the shape of the eye socket. Pressure on the eyelid is adjusted through the adjustment of the strap lengths.
In my co-pending patent application Ser. No. 07/111,809, filed Oct. 21, 1987, entitled "Tapeless Eye Shield Apparatus", the product which is the subject of that application is a generally conventional shield member having head-encircling straps and is designed to avoid the necessity of taping an eye shield to the face of a patient. Eye shields, which differ from splints in that they are not designed to maintain the eyelid in a closed, immobile position, are used simply to prevent accidental injury to the eye and/or exclude light.
It has now been discovered that the construction of an eyelid splint with a flexible, resilient pad having a "low-peel" adhesive for attachment to the inner surface of the backing or shield is highly desirable in certain circumstances. The first advantage is in having the pad "attached" to the splint. This allows removal of the entire device in one piece by either patient or practitioner. This allows repeat exams, showering or application of medicine without having to handle that part of the splint which contacts the eye and is required to be sterile. All eye dressings in current use are composed of 2 to 7 pieces (one or 2 pads plus one to 5 pieces of tape, plus or minus an eye shield). They are very cumbersome to remove and reapply and that part which contacts the eye is easily contaminated.
Construction of the splint with an easily removable pad or "dressing" enables the pad to be easily replaced when wet or soiled without replacing the entire splint. Such a feature is particularly useful for patients having corneal injuries and for post-surgical patients. Corneal injuries are generally treated with antibiotic ointment and an eyelid splint. In general, physicians recommend that the dressing or pad be changed at least every 24 hours as it becomes damp and soiled from the ointment and from eye secretions. Patients may require eyelid splints for at least several days, and occasionally for several weeks. Accordingly, the invention provides the corneal injury patient with a durable (and even washable) backing member and head-encircling straps, both of which are highly desirable features for eyelid splints, but with a dressing that is mountable and detachable from the backing so that it can be replaced quickly and easily. This enables the entirety of the eyelid splint to be reused many times, while replacing the pad as frequently as is desired.
Post-surgical patients often are required to wear an eyelid splint with dressing for one to several days after surgery, and then a protective eye shield with no dressing at bedtime for up to several weeks in order to prevent ocular trauma during sleep. The eyelid splint with removable dressing then enables post-surgical patients to use the splint as described above until a protective eye shield is necessary, at which time the pad or dressing is removed from the interior surface of the splint and the device may then be used as an eye shield as set forth in my co-pending patent application Ser. No. 07/111,809.
According to the invention, the splint comprises a rigid or slightly flexible backing member having a smooth, somewhat concave interior surface, and a pair of adjustable head-encircling straps. The straps are preferably elastic, thereby enabling the wearer to adjust the pressure on the eyelid and to subsequently remove the device and replace the pad. After pad replacement, the splint can be returned into position on the wearer's head without unfastening the straps, thereby obviating retensioning of the straps. A removable foam pad is detachably adhered to the inner surface of the shield by means of a "low-peel" or "permanently removable" adhesive. A preferred method of manufacturing the pad consists of attaching a thin strip of adhesive film to a rear surface of the pad. The film is coated with a "permanent" adhesive on one side, for attachment to the pad, and a low-peel adhesive on the other side for attachment to the shield. The low-peel side is covered with a silicone-coated paper on its surface to protect it until it is ready for attachment to the shield. Adhesives of proper strength are well known and commercially available.
The splint of the invention is easily removed and replaced by a patient or physician since it is a "one-piece" dressing that is easily handled and does not require tape to keep it in place. It is easily adjustable, and can be fit as easily as fitting a hat. In addition to being easily fit and used, however, the device serves a dual purpose since it can be used as an eye shield by removing the pad. Finally, the splint pad is easily replaced with a fresh one without having to purchase an entire new splint.
A number of different head-encircling eye patches are known in the prior art. Examples of eye shields which are designed to cover the eye without contacting the eyelid or eyeball are Wylie, U.S. Pat. No. 591,244, Lush, U.S. Pat. No. 1,161,321, and Werner, U.S. Pat. No. 2,389,223. Various other types of eye bandages which may contain medicine-impregnated pads include Burdick, U.S. Pat. No. 915,738, Robinson, U.S. Pat. No. 1,642,661, Pedersen, U.S. Pat. No. 1,886,725, and Veysey, U.S. Pat. No. 2,024,491. A more complex eye shield which comprises an outer circular frame mounted over a transparent plastic bag filled with fluid to protect and moisten the eye is disclosed in Weiss, U.S. Pat. No. 4,473,370. None of the devices disclosed in the prior art patents show a device designed to immobilize the eyelid and also have a removable dressing pad.
Accordingly, it is an object of the present invention to provide an eyelid splint for immobilizing a patient's eyelid which is self contained as one piece, is comfortable to wear and which has a removable pad member which can be replaced with a new pad member when wet or soiled. It is another object of the invention to provide an eyelid splint having a pad member mounted on an interior surface of a shield by means of a low-peel adhesive. It is yet another object of the invention to provide replacement pads for eyelid splints comprising resilient foam pad members having one surface thereof coated by means of an adhesive having a low-peel strength. A further object of the invention is to provide an eyelid splint which can be used to maintain a wearer's eyelid in an immobilized, closed position, and which also may be used, after removal of the pad member, as an eye shield which protects the wearer's eye from injury yet permits it to open and close at will. These and other objects are achieved by the device of the invention, a specific embodiment of which is described herein.